Clinical Trial: Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study

Brief Summary: Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the efficacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.

Detailed Summary:
Sponsor: Jinling Hospital, China

Current Primary Outcome:

  • the tolerance of enteral nutrition (EN) through nasojejunal tube [ Time Frame: 8 weeks ]
    We defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h.
  • the time oral intake started [ Time Frame: 8 weeks ]
    The time when oral intake (both fluids and solid food) started was noted.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • symptomatic relief [ Time Frame: 8 weeks ]
    The occurrence and severity of each of these symptoms: pain, nausea, vomiting and bloating (each scored as 0 = absent, 1 = mild, 2 = medium, 3 = severe, or 4 = could not be worse) were recorded by nurses blinded to the intervention on a daily basis.
  • scoring evaluation of abdominal CT [ Time Frame: 8 weeks ]
    We use a computed tomography scoring system to evaluate the severity of obstruction.


Original Secondary Outcome: Same as current

Information By: Jinling Hospital, China

Dates:
Date Received: April 2, 2016
Date Started: September 2015
Date Completion: September 2016
Last Updated: August 29, 2016
Last Verified: August 2016